This job has expired

Senior Scientist Biologics Formulation Development

Employer
EyePoint Pharmaceuticals, Inc.
Location
Watertown, Massachusetts, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Consultancy/Private Sector
Field
Development
Discipline
Project Management
Salary Type
Salary
Employment Type
Full time
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Overview:
See Your Future with EyePoint PharmaceuticalsWe are proud to be named a winner of the 2021 Deloitte Technology Fast 500 award, which recognizes the most innovative, fastest-growing companies in North America. Were challenging the status quo in bio tech with a singular focus on vision-saving medications delivered through best-in-class proprietary pharmaceutical technologies and unique internal manufacturing capabilities to transform ocular drug delivery.Our unique culture fosters a science-based entrepreneurial environment, with a collaborative, team-focused approach that embraces diversity, equity and inclusion. Our teams wellbeing is paramount, which is why we offer comprehensive and highly competitive benefits. For self-motivated leaders that are passionate about bio pharmaceuticals and ready to make a difference in the lives of patients, EyePoint Pharmaceuticals is a place you can be a catalyst for change and accelerate your career. If you share our vision for preventing blindness and have a passion for bio tech and disruptive change to improve patient care, review the requirements of this opportunity and apply today!Based in Watertown, MA and reporting to the Director of Formulation Development, this position is responsible for the formulation and process development of dosage forms for in vitro and in vivo preclinical and clinical studies including drug product-device combinations. The individual we are seeking will have a well-established track record of successfully developing drug product formulations and processes from concept to commercialization across multiple modalities. In addition, the successful candidate will have demonstrated capabilities in working cross-functionally with internal stake holders and effectively managing development activities at external vendors.The position holder needs to have a broad range of knowledge across the various functional areas in pharmaceutical development, understand manufacturing technologies, people and organizational structures. The role enables high performing internal and external development teams to successfully develop, commercialize, and file products.EyePoint Pharmaceuticals does not provide relocation assistance. This position is based in Watertown, MA.This position provides the flexibility of work hours. Excellent Compensation Package, including Equity and Comprehensive Benefits upon hire.

Responsibilities:
Primary responsibilities include, but are not limited to, the following:Individual responsibilitiesLeads the development of biologics drug product formulations and drug-device combinations; ensures development activities and timelines are aligned with project goalsPerforms formulation (both biologics and small molecule) development studies and testing in the laboratory.Manages biologics drug product development activities at external vendors Authors and reviews pharmaceutical development reports, CMC sections of regulatory submissions, and other technical documentation Works collaboratively across internal stakeholder functions such as Project Management, Manufacturing Operations Clinical and Regulatory to meet program goals, including representation on development teamsEnsures that all work is conducted in accordance with applicable regulatory standards and guidelines.Maintains an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry

Qualifications:
Primary skills and knowledge required include, but are not limited to the following:Expertise in biologics formulation development, including purification, characterization/analysis, stability, and formulation strategy Experience in biologics drug product development and manufacturing with the understanding of upstream process and downstream process for drug substance; formulation and fill finish for drug productExperience in small molecule formulation development is a plusExperience in developing extended-release formulations is a plusExperience in combination products or devices is a plusExperience in development of ophthalmic products is a plusStrong project management skills with ability to prioritize and align drug product development activities with project goalsKnowledge of current regulatory guidance and experience in regulatory filingsAbility to identify key performance metrics, generate actionable reports and communicate complex information clearly to internal stakeholdersTeam player with excellent interpersonal, technical writing, and oral communication skillsFlexible, adaptable, driven, and collaborative; willing to take on new challenges and positively respond to changesStrong business acumen and problem-solving skills with high integrity and exceptional work ethicTravel domestically or internationally as requiredTravel up to 20% domesticallyInternational travel may be required as EyePoint growsLevel of Education Required: PhD in Pharmaceutical Sciences, Molecular Biology, or related discipline Number of Years of Experience in the Function and in the Industry: At least 5 years of relevant experience in pharmaceutical developmentWe are an ophthalmology focused companycommitted todeveloping and commercializing innovativeophthalmic products in indications withhigh unmet medical needtoimprove the lives of patientswithserious eye disordersEyePoint Company Values include:Success begins with our People our employees are valued, relied upon and key to our companys successPatient First above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patientsIntegrity we are always honest, open, ethical and fairResults-Driven we are decisive and act with a sense of urgency against clear and aggressive goalsInnovation we strive for continuous improvement through thoughtful risk-takingTeam Focus we work and communicate in a collaborative, respectful and inclusive fashionDiversity & Inclusion-We commit to diversity in our staff and embrace inclusion and acceptance of others without biasEyePoint Pharmaceuticals is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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